MAUDE Adverse Event Report: BIODERM, INC. MEN'S LIBERTY; EXTERNAL CATHETER

Model Number	23046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's wife reported the patient has had two utis since he started to use men's liberty external catheter in (b)(6) 2021.Patient's wife stated he was hospitalized for both infections and is in a rehab center now.Patient's wife stated he has been cleared of the infection by his doctor, is still taking antibiotics, and is still using men's liberty.Product specialist went over the application steps and explained proper positioning of the device to allow urine to flow away from the anatomy with gravity.Patient or patient's wife did not report this to bioderm previously.
Additional Manufacturer Narrative
Manufacturing records for this lot were reviewed, and there were no discrepancies noted.There were no nonconformances associated with this lot.Hospital and/or doctor's notes confirming the uti or hospitalization were requested and never received.Doctor's notes listing medical history during initial patient set-up were reviewed.Patient notes dated (b)(6) 2021 list that the patient has a history of urinary retention, lower urinary tract symptoms, ureteral calculous obstruction, and feeling of incomplete bladder emptying.Report will be updated if further notes are received.Incontinence patients are at a higher risk for infection.Per the patient's wife, his doctor cleared him of infection, and they are still using the device.There is no confirmed history of infection related to our product.There is no indication that the device failed to meet specifications or malfunctioned, and the cause is not established.

• Brand Name: MEN'S LIBERTY
• Common Device Name: EXTERNAL CATHETER
• Manufacturer (Section D): BIODERM, INC.; 12320 73rd court n; largo FL 33773
• Manufacturer Contact: 12320 73rd court n; largo, FL 33773
• MDR Report Key: 14856110
• Report Number: 3001949129-2022-00005
• Device Sequence Number: 4878052
• Product Code: NOA
• UDI-Device Identifier: 00653599000168
• UDI-Public: 00653599000168
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 23046
• Device Lot Number: G31901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male